Device and Method for Deployment of an Anchoring Device for Intervertebral Spinal Fusion

ABSTRACT

A device and methods for intervertebral spinal fusion of adjacent intervertebral bodies. An intervertebral spacer is positioned within a narrow disc space between adjacent intervertebral bodies of a patient. The spacer is arranged with upper and lower guides. The guides are adapted to simultaneously guide the deployment of upper and lower anchors of an anchoring device into their respective intervertebral bodies. The spacer is also adapted to lock the upper and lower anchors to the spacer in the deployed position.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is continuation of U.S. patent application Ser.No. 16/191,811, filed Nov. 15, 2018, which is a continuation-in-part ofU.S. patent application Ser. No. 15/417,331, filed Jan. 27, 2017, whichis a continuation-in-part application of U.S. patent application Ser.No. 14/881,703, filed Oct. 13, 2015, which is a continuation-in-partapplication of U.S. patent application Ser. No. 14/718,514, filed May21, 2015, which are each incorporated by reference in their entiretiesherein for all purposes.

FIELD OF THE INVENTION

The present invention relates generally to intervertebral spacers forfusing adjacent vertebras, and more particularly to a device and methodsfor doing so.

BACKGROUND

Intervertebral spinal fusion is well known in the art. In the prior art,an intervertebral spacer is implanted between two adjacentintervertebral bodies. The spacer allows a surgeon to deposit bone graftbetween the problem vertebras in order to fuse the vertebras together.To achieve proper fusion, the implanted spacer must be securely anchoredbetween the vertebras such that there is little to no movement onceimplanted. Protrusions arranged on the superior and inferior surfaces ofthe spacer provides a means to stabilize the spacer between thevertebras. However, it has been discovered that spacers stabilized inthis way may still move due to the stress exerted on the implantedspacer when the patient moves. Other commonly employed stabilizingtechniques include pedicle screws and rods. In this technique, pediclescrews are independently screwed into two or three spine segments. Ashort rod is then used to connect the pedicle screws to prevent motionat the segments that are being fused. However, this technique is timeconsuming because the pedicle screws need to be independently screwedinto the vertebras. It also requires the surgeon to make large/numerousincisions in the patient to insert the pedicle screws. Because of thesedeficiencies in the prior art, there exists a need to provide a moreeffective and efficient way of stabilizing adjacent vertebras in thefield of intervertebral spinal fusion.

SUMMARY

For the purpose of the following description and the appended claims,“proximal” and its inflected forms are defined as the part, portion,section, etc., of an object that is closest to the person using thatobject.

For the purpose of the following description and the appended claims,“distal” and its inflected forms are defined as the part, portion,section, etc., of an object that is furthest away to the person usingthat object.

The present invention provides a way to stabilize adjacent vertebraswithout some of the deficiencies of the prior art discussed above. In anillustrative embodiment, a spacer is provided with an upper guide and alower guide. The upper and lower guides are adapted to guide thesimultaneous deployment of a respective upper anchor and lower anchor ofan anchoring device when force is applied thereto. More precisely, forceis simultaneously applied to a proximal portion of the upper and loweranchors. The force simultaneously deploys the upper and lower anchorsinto their respective intervertebral bodies. The upper and lower anchorsare constructed and dimensioned in such a way to pierce and penetrateinto their respective vertebras. The combination of the anchors and theprotrusions arranged on the surfaces of the spacer provides additionalstabilization of the implanted spacer. These advantages of the presentinvention will be apparent from the following disclosure and theappended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A depicts a perspective view of an intervertebral spacer inaccordance with an illustrative embodiment of the present invention;

FIG. 1B depicts another perspective view of the intervertebral spacer ofFIG. 1A;

FIG. 2A depicts a top view of the intervertebral spacer of FIGS. 1A and1B;

FIG. 2B depicts a side view of the intervertebral spacer of FIGS. 1A and1B;

FIG. 3A depicts one side of an anchor in accordance with an illustrativeembodiment of the present invention;

FIG. 3B depicts the other side of the anchor of FIG. 3A;

FIG. 4A depicts two anchors being loaded into the intervertebral spacerof FIGS. 1A and 1B;

FIG. 4B depicts the two anchors of FIG. 4A loaded into theintervertebral spacer of FIGS. 1A and 1B, the two anchors being in anundeployed state;

FIG. 5A depicts a perspective view of an implantation instrument inaccordance with an illustrative embodiment of the present invention;

FIG. 5B depicts a cross-sectional view of the implantation instrument ofFIG. 5A, the cross-sectional view depicting a narrower section and awider section of the implantation instrument;

FIG. 5C depicts an exploded, cross-sectional view of the wider sectionof the implantation instrument of FIG. 5A;

FIG. 5D depicts a cross-sectional view of the implantation instrumentgripping the lateral surfaces of the intervertebral spacer of FIGS. 1Aand 1B;

FIG. 6A depicts the implantation instrument of FIG. 5A having deployedthe anchors of FIG. 4A;

FIG. 6B depicts an exploded, top view of the deployed anchors of FIG.6A;

FIGS. 6C and 6D depict an exploded, perspective view of the deployedanchors of FIG. 6A;

FIG. 7A-7C depict a spacer and anchor in accordance with an alternativeembodiment of the present invention, wherein the upper and lower anchorsof the anchoring device form a single, unitary piece;

FIG. 8A-8C depict a spacer and anchor in accordance with an alternativeembodiment of the present invention, wherein the upper and lower anchorsof the anchoring device are disposed entirely within the spacer;

FIG. 9A-9H depict an upper anchor and a lower anchor arranged on a driveplate in accordance with an alternative embodiment of the presentinvention; and

FIG. 10 depicts a spacer having worm gear for deploying one or moreanchors in accordance with an alternative embodiment of the presentinvention.

FIG. 11 depicts an implant according to another embodiment of thepresent invention.

FIG. 12 depicts a spacer body of the implant illustrated in FIG. 11

FIGS. 13 and 14 perspective views of the spacer body according to oneembodiment of the present invention.

FIGS. 15 and 16 depict the anchors of the implant illustrated in FIG.11.

FIG. 17 depicts a lateral view of the implant according to oneembodiment of the present invention.

FIG. 18 depicts a perspective view of the implant of FIG. 11.

FIG. 19 depict an actuation member according to one embodiment of thepresent invention.

FIGS. 20 and 21 depict a lateral view of the implant when the anchorsare in an undeployed and deployed state.

FIGS. 22 and 23 illustrate an instrument coupled to the implant when theanchors are in an undeployed and deployed state.

FIG. 24 depicts a top perspective view of an alternative spacer andanchor system in an undeployed state accordance with some embodiments.

FIG. 25 depicts a top perspective view of the spacer and anchor systemof FIG. 24 in a deployed state.

FIG. 26 depicts a side view of the spacer and anchor system of FIG. 24in an undeployed state.

FIG. 27 depicts a side view of the spacer and anchor system of FIG. 24in a deployed state.

FIG. 28 depicts a front perspective view of the spacer of FIG. 24.

FIG. 29 depicts a top view of the spacer of FIG. 28.

FIG. 30 depicts a top view of a carrier of the spacer and anchor systemof FIG. 24.

FIG. 31 depicts a side view of a carrier of the spacer and anchor systemof FIG. 24.

FIG. 32 depicts a side perspective view of an anchor of the spacer andanchor system of FIG. 24.

FIG. 33 depicts a side perspective view of a revision instrument inaccordance with some embodiments.

FIG. 34 depicts a side cross-sectional view of an alternative spacer andanchor system in accordance with some embodiments.

FIG. 35 depicts a cross-sectional, exploded view of the spacer andanchor system of FIG. 34.

FIG. 36 depicts a top perspective view of a spacer in accordance withsome embodiments.

FIG. 37 depicts a side perspective view of a carrier in accordance withsome embodiments.

FIG. 38 depicts a top perspective view of a rotator in accordance withsome embodiments.

FIG. 39 depicts a top perspective view of an anchor in accordance withsome embodiments.

FIG. 40 depicts the spacer and anchor system of FIG. 34 including aninserter in accordance with some embodiments.

FIG. 41 depicts the spacer and anchor system of FIG. 34 including aninserter and threaded sleeve in accordance with some embodiments.

FIG. 42 depicts the spacer and anchor system of FIG. 34 including aninserter, threaded sleeve and key instrument prior to rotation of therotator, in accordance with some embodiments.

FIG. 43 depicts the spacer and anchor system of FIG. 34 including aninserter, threaded sleeve and key instrument following rotation of therotator, in accordance with some embodiments.

FIG. 44 depicts a top perspective view of the spacer and anchor systemof FIG. 34.

FIG. 45 shows a side perspective view of a spacer and anchor system inaccordance with some embodiments.

FIG. 46 show the spacer and anchor system of FIG. 45 with the anchors ina deployed condition.

FIG. 47 shows a rear perspective view of the spacer of FIG. 45 with theanchor omitted for clarity.

FIG. 48 shows a side view of the spacer of FIG. 45.

FIG. 49 shows a top down cross-sectional view of the spacer of FIG. 45.

DETAILED DESCRIPTION

FIGS. 1A and 1B depict perspective views of intervertebral spacer 100 inaccordance with an illustrative embodiment of the present invention.Spacer 100 generally has a rectangular shape, but the present inventionis not limited to such a shape. Spacer 100 can have any shape, size, orcombination thereof to meet the needs of a spinal fusion candidate.

As depicted in FIGS. 1A and 1B, spacer 100 comprises superior surface102, inferior surface 104, lateral surfaces 106 and 108, distal portion110, and proximal portion 112. Inferior surface 104 is a mirror image ofsuperior surface 102 and lateral surface 108 is a mirror image oflateral surface 106. Spacer 100 is preferably formed from titanium alloybut other biocompatible materials (e.g., polyetheretherketone (PEEK),other surgical grade metals, alloys, or a combination thereof) can alsobe used to form spacer 100.

Beginning at distal portion 110, spacer 100 is constructed to have atapered end that narrows towards the distal most end. This design helpsfacilitate easier entry of spacer 100 into the narrow disc spacearranged between two adjacent vertebral bodies.

To fuse the adjacent vertebras together, bone graft is used. For thispurpose, the body of spacer 100 is provided with through-hole 114. Thethrough-hole extends through the center of surfaces 102, 104, 106, and108 and is adapted to receive the bone graft for fusing the adjacentvertebras. In the illustrative embodiment, through-hole 114 generallyhas a rectangular shape. However, those skilled in the art willappreciate after reading this disclosure that through-hole 114 can haveany shape, size, or a combination thereof. As further depicted in FIGS.1A and 1B, surfaces 102 and 104 are provided with a plurality ofprotrusions or teeth 116 to help prevent spacer 100 from expulsion afterbeing implanted between the adjacent vertebras. It will be appreciatedby those skilled in the art, after reading this disclosure, that teeth116 can be angled in any number of degrees (e.g., 45°, 90°, etc.) andcan have any number of orientations without departing from the scope ofthe present invention. Through-hole 114 and teeth 116 can be seen moreclearly in FIGS. 2A and 2B.

Turning now to proximal portion 112, upper and lower guides are providedto respectively guide the deployment of upper anchor 118 and loweranchor 120 into their respective vertebral bodies. The upper and loweranchors will be discussed in more detail below, with respect to FIGS. 3Aand 3B. In the illustrative embodiment, the upper guide is characterizedby an upper inclined surface 122 (e.g., a curvilinear surface, etc.) andan upper pair of oppositely positioned lateral recesses 124. Because thelower guide is a mirror image of the upper guide, the lower guide isalso characterized by a lower inclined surface 126 and a lower pair ofoppositely positioned lateral recesses 128. The upper and lower pair oflateral recesses 124 and 128 are dimensioned to respectively complementthe arc, curvature, etc., of the upper and lower anchors. An advantageof recesses 124 and 128 is that they ensure that their respectiveanchors maintain a desired trajectory when impacted by an anchor driver.The recesses 124 and 128 also prevent their respective anchors fromegressing out of spacer 100 when impacted by the anchor driver. Thesefeatures and their advantages will be discussed in more detail below,with reference to FIGS. 4A and 4B.

Proximal portion 112 also comprises a pair of oppositely positionedlateral chamfers 130 and 132. Each of the lateral chamfers has a slopingedge and is positioned proximally to their respective locking recesses134, 136, 138, and 140. As will be described in more detail below, withreference to FIGS. 6A-6D, the chamfer-recess combination is a mechanismthat allows upper anchor 118 and lower anchor 120 to be locked to spacer100 after deployment. It will be appreciated by those skilled in theart, after reading this disclosure, that locking recesses 134, 136, 138,140 could be detents in some embodiments and through-holes in otherembodiments.

Proximal portion 112 further comprises lateral surfaces 142 and 144 thatare respectively constructed with gripper recesses 146 and 148. Thegripper recesses are dimensioned and arranged to receive correspondingribs of an implantation instrument employed by a surgeon. The ribs areadapted to fit squarely into their corresponding recesses so that spacer100 can be securely gripped by the surgeon. It should be noted thatgripping the spacer with an implantation instrument serves at least twopurposes. First, it enables the surgeon to more easily orient spacer 100in a desired position within the narrow disc space of the adjacentvertebras. Secondly, it prevents spacer 100 from coming free from theimplantation instrument while the surgeon is impacting the upper andlower anchors with an anchor driver. Although each of the lateralsurfaces is depicted as having three gripping recesses, it will beappreciated by those skilled in the art that each of the lateralsurfaces can have more or less gripper recesses than depicted. Thisfeature of the present invention will be described in more detail below,with reference to FIGS. 5A-5D.

FIGS. 3A and 3B are perspective views of an anchor in accordance with anillustrative embodiment of the present invention. Since upper anchor 118and lower anchor 120 have substantially the same physical and functionalcharacteristics, thus being interchangeable, the following discussion ofFIGS. 3A and 3B will use the word “anchor” to describe both the upperand lower anchors. Further, it should be noted that upper anchor 118 andlower anchor 120 (whether formed as independent pieces or as a singleunitary piece) collectively define an anchoring device.

FIG. 3A depicts the surface of an anchor that is adapted to slide alongan inclined surface of a guide (e.g., upper inclined surface 122 orlower inclined surface 126). In the illustrative embodiment, the anchoris constructed to have a curved or semi-curved surface that is contouredto be substantially the same as the inclined surface of the guide itslides on. The surface of the anchor is preferably smooth throughout itslength in order to reduce the amount of friction drag produced when thesurface slides along the inclined surface.

The anchor also comprises a pair of oppositely positioned lateral sides302 and 304, which are adapted to slide into their respective lateralrecesses (e.g., upper lateral recesses 124 or lower lateral recesses128). The anchor is also constructed with a pair of flexible prongs 306and 308, which respectively comprises lateral projections 310 and 312.The flexible prongs and lateral projections work in cooperation to lockthe anchor to spacer 100 in a deployed position. The lateral sides,flexible prongs, and lateral projections of the anchor are also depictedin FIG. 3B.

To enable the anchor to penetrate a vertebral body, distal portion 314of the anchor is tapered to form an edge. Since the anchor is made oftitanium alloy, the distal portion of the anchor is sufficiently strongto pierce and penetrate through the endplate of the vertebral body.Although the anchor is preferably formed from titanium alloy, otherbiocompatible materials (e.g., polyetheretherketone (PEEK), othersurgical grade metals, alloys, or a combination thereof) can be used toform the anchor.

It will be clear to those skilled in the art that the foregoingdiscussion of FIGS. 3A and 3B applies to both upper anchor 118 and loweranchor 120.

FIG. 4A depicts upper anchor 118 and lower anchor 120 being loaded intospacer 100. As discussed above, the upper guide of spacer 100 has anupper pair of oppositely positioned lateral recesses 124. Each lateralrecess 124 is adapted to receive a respective one of lateral sides 302and 304 of upper anchor 118. Similarly, the lower guide of spacer 100has a lower pair of oppositely positioned lateral recesses 128 (shownmore clearly in FIG. 1B). Each lateral recess 128 is adapted to receivea respective one of lateral sides 302 and 304 of lower anchor 120.Turning now to FIG. 4B, this figure depicts spacer 100 loaded with theupper and lower anchors. In FIG. 4B, upper anchor 118 and lower anchor120 are in an undeployed state and are disposed entirely within spacer100. That is, no part of upper anchor 118 and lower anchor 120 extendbeyond the profile of teeth 116 arranged on spacer 100. In theloaded/undeployed state, spacer 100 is ready to be gripped by animplantation instrument for simultaneous deployment into theirrespective intervertebral bodies.

FIG. 5A is a perspective view of implantation instrument 500, whichcomprises, inter alia, housing 502, anchor driver 504, handle 506, and apair of oppositely positioned grippers 508 and 510. As will be discussedin more detail below, with reference to FIGS. 5B-5D, anchor driver 504can be advanced forwards or retracted backwards via handle 506 torespectively grip or release spacer 100.

FIG. 5B is a cross-sectional view of the implantation instrument of FIG.5A. As shown in this view, housing 502 is divided into two sectionsnamely, a narrower section 512 and a wider section 514. Anchor driver504 is constructed to fit squarely into narrower section 512 with littleor no lateral and radial movement, while the area of wider section 514is dimensioned to accommodate the width of anchor driver 504 and a pairof adjacently positioned, oppositely bowed leaf springs 516 and 518.

In the configuration depicted in FIG. 5B, anchor driver 504 can beadvanced forwards towards leaf springs 516 and 518 via handle 506. Asthe forward advancement causes anchor driver 504 to be wedged betweenleaf springs 516 and 518, their respective grippers 508 and 510 willbegin to simultaneously pivot inward to clamp onto the lateral surfacesof spacer 100.

More precisely, and with reference to FIG. 5C, the forward advancementof anchor driver 504 causes gripper 508 to pivot inwardly about pivotpoint 520. This pivot action is a result of leaf spring 516 beingcompressed outwards towards the wall of housing 502 as anchor driver 504engages the bowed portion of leaf spring 516. As gripper 508 pivotsinwards, ribs 524 engage their respective gripper recess 146 (depictedin FIG. 1A) arranged on spacer 100. Likewise, gripper 510 will pivotinwardly about pivot point 522 in response to the forward advancement ofthe driver, resulting in ribs 526 engaging their respective gripperrecess 148 (depicted in FIG. 1B). By means of the foregoing, spacer 100can be securely gripped by implantation instrument 500, as depicted inFIG. 5D.

As depicted in FIG. 5D, the head of anchor driver 504 stops at orslightly before the distal end of housing 502 after gripping spacer 100.While spacer 100 is being gripped by implantation instrument 500, spacer100 is positioned within the narrow disc space between adjacentvertebras. Continuing to grip spacer 100 with implantation instrument500, the surgeon removes cap 530 and is now ready to impact handle 506with a weighted object (e.g., hammer, mallet, etc.). In accordance withthe illustrative embodiment, cap 530 has two functionalities. First, cap530 when attached to handle 506 disallows forward movement of anchordriver 504 past a certain point—namely, the distal end of housing 502.Secondly, cap 530 prevents inadvertent deployment of upper anchor 118and lower anchor 120 during positioning of spacer 100 within theadjacent vertebral bodies.

When the surgeon impacts handle 506 with a weighted object, anchordriver 504 is driven forwards into the proximal portion of upper anchor118 and lower anchor 120, thereby simultaneously deploying the anchorsinto their respective vertebras. The surgeon may impact handle 506 oneor more times so that the anchors reach a desired depth within theirvertebras, and so that the anchors engage the locking feature describedin more detail below. Once upper anchor 118 and lower anchor 120 islocked to spacer 100 in the deployed position, the surgeon can retractanchor driver 504 so that leaf springs 516 and 518 can return to theirrelaxed state. While returning to their relaxed state, grippers 508 and510 will begin to pivot outwardly to disengage from their gripperrecesses, thereby releasing spacer 100.

FIG. 6A depicts a perspective view of implantation instrument 500 inwhich driver anchor 504 has simultaneously deployed upper anchor 118 andlower anchor 120. As discussed above, the head of anchor driver 504 issimultaneously driven into the proximal portion of upper anchor 118 andlower anchor 120 as the surgeon impacts handle 506. This causes both theupper anchor 118 and lower anchor 120 to independently slide along theupper inclined surface 122 and lower inclined surface 126, respectively.The upper and lower inclined surfaces respectively press against thesurface of the upper and lower anchors (i.e., the surface depicted inFIG. 3A) to deploy the anchors into their respective vertebral bodies.FIGS. 6B-6D depict upper anchor 118 and lower anchor 120 simultaneouslydeployed after being impacted by anchor driver 504. As shown in thesefigures, the distal ends of upper anchor 118 and lower anchor 120 in thedeployed state are radially extended outside of spacer 100. That is, thedistal ends of upper anchor 118 and lower anchor 120 extend past theheight of teeth 116 of spacer 100 after being deployed.

From the foregoing discussion, it will be clear to those skilled in theart that upper anchor 118 and lower anchor 120 are separate elementsthat slide independently of each other along their respective upper andlower guides. It will also be clear from the foregoing discussion thatan advantage of using the upper and lower anchors is that they provideadditional anchorage for stabilizing a spacer. In other words, not onlyis the spacer anchored to the intervertebral bodies via its teeth, thespacer is also provided with additional anchorage by the upper and loweranchors, since they extend past the profile of the teeth and thereforepenetrating deeper into the intervertebral bodies.

Returning to FIGS. 6C and 6D, these figures depict upper anchor 118 andlower anchor 120 locked to spacer 100 in a deployed position. Sinceupper anchor 118 and lower anchor 120 are locked to spacer 100 insubstantially the same way, the following discussion of FIGS. 6C and 6Dwill use the word “anchor” to describe both the upper and lower anchors.

As the anchor is impacted by driver 504, lateral projections 310 and 312will respectively engage the sloping edge of lateral chamfers 130 and132. Lateral chamfers 130 and 132 are depicted in the figures as beingarranged proximally to locking recesses 134, 136, 138, and 140 of spacer100. The pressure and force of the impact causes flexible prongs 306 and308 to flex laterally inwardly. As lateral projections 310 and 312 pasttheir respective lateral chamfers, flexible prongs 306 and 308 willreturn to a relaxed state, thereby causing lateral projections 310 and312 to laterally extend into their corresponding locking recess 134,136, 138, and 140. This locking feature prevents the anchors fromdisengaging from spacer 100 after being deployed into the vertebralbodies.

It will be clear to those skilled in the art, after reading thisdisclosure that numerous modification can be made to the illustrativeembodiment without departing from the scope of the invention. Forexample, in one alternative embodiment, upper anchor 118 and loweranchor 120 can be constructed as a single unitary piece. FIGS. 7A-7Cdepict such an anchoring device.

As depicted in FIG. 7A, upper anchor 702 of anchoring device 700comprises underside 704 that is adapted to press against upper inclinedsurface 706 of the upper guide arranged on spacer 100. Similarly, loweranchor 708 of anchoring device 700 comprises underside 710 that isadapted to press against lower inclined surface 712 of the lower guidearranged on spacer 100. As anchoring device 700 is advanced forwards,pressure causes the undersides to press against their respectiveinclined surfaces, which guides upper anchor 702 and lower anchor 708 toradially and simultaneously deploy into their respective vertebralbodies. As depicted in FIGS. 7B and 7C, upper anchor 702 and loweranchor 708 extend past the profile of teeth 714 to provide additionalanchorage. Once the upper and lower anchors have been simultaneouslydeployed into their vertebra, locking cap 716 can be used to lock theanchors in their deployed position. Specifically, locking cap 716 isadapted to press the proximal end of anchoring device 700 to lock theanchoring device to spacer 100.

In another embodiment, as depicted in FIGS. 8A-8C, spacer 100 housesboth upper anchor 802 and lower anchor 804. In other words, both theupper and lower anchors are disposed entirely within spacer 100 when theanchors are in a relaxed state. As shown in FIG. 8B, an internal drivescrew 806 (i.e., an anchor drive) can be turned so that wedge 812 can beadvanced forwards towards the bowed portion of both upper anchor 802 andlower anchor 804. Wedge 812 is forcibly advanced towards the bowedportion to simultaneously force upper anchor 802 and lower anchor 804 toextend through an opening arranged on superior surface 808 and inferiorsurface 810 of spacer 100. More precisely, as drive screw 806 is turned,wedge 812 abuts against the bowed portion of upper anchor 802 and loweranchor 804. As wedge 812 abuts against the bowed portion of the anchors,the inclined surface of wedge 812 slides along the surface of upperanchor 802 and lower anchor 804. The sliding motion applies pressure tothe surfaces of the anchors, thereby forcing both upper anchor 802 andlower anchor 804 to radially extend outside of the openings of spacer100 and into their respective intervertebral bodies.

In a further embodiment, as depicted in FIGS. 9A-9H, the anchoringdevice has a drive plate 906 from which upper anchor 902 and loweranchor 904 extend.

The drive plate of FIG. 9A includes through-hole 908 arranged at itscentral axis. The drive plate can be divided into four quadrants, withthrough-hole 908 being the origin point, like in a two-dimensionalCartesian plane. Upper anchor 902 extends from a first one of thequadrants (e.g., Quadrant I in a two-dimensional Cartesian plane), whilelower anchor 904 extends from a second one of the quadrants (e.g.,Quadrant III in the two-dimensional Cartesian plane), wherein the firstand second quadrants are diagonally located from each other on driveplate 906. Although the anchors have been described as having a specificarrangement on drive plate 906, it will be clear to those skilled in theart after reading this disclosure that upper anchor 902 and lower anchor904 can be arranged anywhere on the drive plate without departing fromthe scope of the present invention.

As further depicted in FIG. 9A, each of upper anchor 902 and loweranchor 906 has a pointed tip and a plurality of projections arranged ontheir lateral surfaces. The plurality of projections can be, forexample, and without limitation, barbs that are angled away from thepoint in which the anchors penetrate into their respective vertebras.The barbs are advantageous because they make it difficult for theanchors to come loose, thus ensuring that the spacer is securelystabilized between the vertebras after implantation. FIG. 9A alsodepicts a pair of oppositely positioned grippers of holder 910 grippingonto the lateral surfaces of drive plate 906.

Turning now to FIG. 9B, while drive plate 906 is gripped by holder 910,a surgeon can position the grippers of holder 910 to also grip ontoendplate 912 of spacer 900. Once endplate 912 is gripped by the surgeon,a driver 914 can be inserted into holder 910, which passes throughthrough-hole 908 of drive plate 906. The driver engages one end of drivescrew 916 (shown in FIG. 9C) housed within spacer 900. Once the driverhas engaged the drive screw, the surgeon can turn driver 914 so thatdrive screw 916 can be threaded into the body of wedge 918. This causeswedge 918 to move backwards towards the proximal end of spacer 900,which in turn causes superior surface 920 and inferior surface 922 ofthe spacer to slide along the inclined surface of wedge 918. This can beseen more clearly in FIGS. 9C and 9D. As superior surface 920 andinferior surface 922 radially extend in opposite directions of eachother, upper anchor 902 and lower anchor 904 engage upper guide 924 andlower guide 926 of spacer 900. As shown in FIG. 9D, the tips of upperanchor 902 and lower anchor 904 do not extend past the profile of teeth928 of spacer 900, even after superior surface 920 and inferior surface922 have been fully extended.

Once the superior and inferior surfaces of spacer 900 have been fullyextended, the surgeon can now retract driver 914 and insert pull screw930 (i.e., anchor driver) as shown in FIG. 9E. Pull screw 930 isphysically adapted to be inserted through through-hole 908 and into thethreaded hole of drive screw 916. Pull screw 930 can now be threaded toadvance drive plate 906 towards the proximal end of spacer 900, whichcauses upper anchor 902 and lower anchor 904 to respectively slide alongupper guide 924 and lower guide 926 as the drive plate is advancedtowards the proximal end of the spacer. As upper anchor 902 and loweranchor 904 slide along their respective guides, the anchorssimultaneously and radially extend away from spacer 900 and into theirrespective intervertebral bodies. Pull screw 930 is threaded by thesurgeon until drive plate 906 is fully seated against endplate 912. Notonly does threading pull screw 930 in this way fully deploy the anchorsinto their respective intervertebral bodies, it also locks the anchorsto spacer 900 in a deployed position, as shown in FIGS. 9F-9H.

FIG. 10 depicts a spacer-anchor combination in accordance with analternative embodiment of the present invention. More specifically, thefigure depicts spacer 1000, a plurality of upper anchors 1002, worm1004, and gear 1006. In accordance with this embodiment, the worm isphysically adapted to turn the gear, but the gear cannot turn the worm.This is because the angle on the worm is so shallow that, when the geartries to spin it, the friction between the gear and the worm holds theworm in place. With this in mind, a surgeon can implant spacer 1000 inthe disc space of adjacent vertebras. The surgeon can then use a tool toturn worm 1004 in order to rotate gear 1006 in a particular direction.As the gear rotates, upper anchors 1002 are simultaneously deployed intoan intervertebral body. Once deployed, pressure from adjacent vertebrascompressing down onto gear 1006 will not cause the gear to rotate. Thisis because, as discussed above, the angle on the worm is so shallow thatthe friction between the gear and the worm essentially locks the worm inplace. Accordingly, upper anchors 1002 will be locked in their deployedposition until worm 1004 is operated.

FIGS. 11-23 disclose yet another embodiment of the present invention.FIG. 11 illustrates a spinal implant 2000 that includes a spacer body2002, a first anchor 2004, a second anchor 2006 and an actuation member2008. The spacer body 2002 as illustrated in FIGS. 12-14 in greaterdetail includes an anterior portion 2010, a posterior portion 2012, anupper surface 2014, a lower surface 2016 opposing the upper surface2014, a first lateral surface 2018 and a second lateral surface 2020.The spacer body 2002 also includes a channel 2022 that extends from theanterior portion 2010 to the posterior portion 2012. There is also athrough hole 2024 that extends from the upper surface 2014 to the lowersurface 2016. These features can be more clearly seen in FIGS. 13 and14.

The upper surface 2014 and the lower surface 2016 of the spacer body2002 may also be configured to include protrusions such teeth, ridges,and/or spikes to grip the adjacent vertebral bodies. The through-hole2024 extending from the upper surface to the lower surface of the spacermay be configured and dimensioned to be in any geometric shape, i.e.rectangular, elliptical, or irregular. The spacer body 2002 isconfigured with a length, a height and a width, wherein the length ofthe spacer body 2002 is greater than the width. However, in otherembodiments, the spacer body 2002 may be configured so that the width isgreater than the length.

The anterior portion 2010 of the spacer body 2002 may be configured tobe tapered for ease of insertion. The channel 2022 that extends from theanterior portion 2010 to the posterior portion 2012 has a greaterdiameter at a posterior portion of the spacer body 2002 than theanterior portion 2010 of the spacer body 2002. The channel 2022 extendsthe length of the implant so that the insertion of the implant into theintervertebral space may be accomplished anteriorly and/or posteriorly.The spacer body 2002 also includes features to retain the actuationmember 2008. In the preferred embodiment, the inner surface of theposterior portion includes actuation member retention features such asnotches and/or grooves which engage with a head of the actuation member2008. It should be noted that in other embodiments the channel 2022 maybe configured with ratcheting teeth that engage with the actuationmember. In another alternative embodiment, the channel 2022 may includethreads allowing the actuation member to translate within the implant.The translation of the actuation member then causes the anchors whichare coupled to the actuation member to be guided into the adjacentvertebral bodies. Additionally, in another embodiment, the implant isprovided with ramps, having similarly shaped anchors 2004, 2006. Theactuation method involves pulling the anchors 2004, 2006 toward the rampwith an actuation member that is a shouldered drive screw. Theshouldered drive screw is moved anteriorly or posteriorly with a nutattached to the spacer body.

The posterior portion 2012 of the spacer body 2002 includes slots 2026for receiving an instrument/holder as illustrated in FIG. 20. The firstand second slots 2026 are configured to extend from the posteriorsurface of the spacer body 2002 to the first and second lateral surfacesof the spacer body 2002 respectively. The first and second lateralsurfaces 2018, 2020 also include a first window 2028 and a second window2030 which are configured to extend from the first and second lateralexterior surface to lateral inner surfaces of the spacer body 2002. Thefirst and second windows 2028, 2030 are also configured to receive afirst protrusion 2032 and a second protrusion 2032 of the anchors 2004and 2006, which are discussed in greater detail with reference to FIGS.15 and 16. Specifically, anchors 2004 and 2006 are positioned on theinner lateral walls of the spacer body 2002 within grooves 2029, 2031configured on the inner surfaces of the first and second lateral walls.

FIGS. 15 and 16 illustrate the anchors 2004, 2006 in greater detail. Theanchors 2004 and 2006 have substantially the same physical andfunctional characteristics. Each of the anchors 2004, 2006 are with arhomboid profile with a teeth cut. On a first side of each anchor is aprotrusion 2032 that engages with the window in the spacer body 2002. Ona second side of each anchor 2004, 2006 are linear cuts 2034 of a threadprofile. The cuts 2034 are only interrupted by a chamfer which bringsthe teeth 2036 to a sharp edge. In the preferred embodiment, the anchors2004, 2006 are configured as uncurled half-nuts. The angle between thethread profile trajectory and side profile of the anchors 2004, 2006match the helix angle of the actuator member 2008. It should be notedthat in other embodiments the anchors 2004, 2006 may be configured withdifferent types of thread profiles that correspond to the actuatormember. The anchors 2004 and 2006 once positioned within the spacer body2002, are retained within the spacer body 2002 as the protrusions 2032are fitted in to the windows 2028, 2030 of the lateral walls of thespacer body 2002, as shown in FIGS. 17 and 18. To enable the anchor topenetrate a vertebral body, distal portion of the anchor is tapered toform an edge. Since the anchors are made of titanium alloy, the distalportion of the anchors are sufficiently strong to pierce and penetratethrough the endplate of the vertebral body. Although the anchors arepreferably formed from titanium alloy, other biocompatible materials(e.g., polyetheretherketone (PEEK), other surgical grade metals, alloys,or a combination thereof) can be used to form the anchor.

The first and second anchors 2004, 2006 are separate elements that maybe configured to move independently of each other along theirgrooves/respective guides 2029, 2031. It will also be clear from theforegoing discussion that an advantage of using the first and secondanchors 2004, 2006 is that they provide additional anchorage forstabilizing a spacer.

In operation as the anchors 2004, 2006 are moved by rotating theactuator member 2008, the protrusions 2032 positioned within the windows2028, 2030 limit the anchors 2004, 2006 motion to a maximum distance. Itshould be noted that the windows 2028, 2030 may be configured toincrease or decrease the amount of the maximum distance the anchors2004, 2006 may be moved into the vertebral bodies. The angles of thewindows 2028, 2030 may also be designed to provide greater or lesserangulation of the anchors 2004, 2006 when actuated into the vertebralbodies.

FIG. 18 illustrates a perspective view of the implant 2000. As shown,the spacer body 2002 includes a through hole 2024 the extends from theupper surface to the lower surface of the implant and a first groove2029 and a second groove 2031 that extend at an angle from the lowersurface to the upper surface, as illustrated in FIG. 12. The grooves2029, 2031 are configured to receive each one of the anchors 2004, 2006.The first and second grooves 2029, 2031 act as guides so that the firstgroove 2029 guides the first anchor 2004 into one vertebral body and thesecond groove 2031 guides the second anchor 2006 into the anothervertebral body. The first and second grooves 2029, 2031 are configuredat an angle between the vertical and horizontal axis of the spacer body2002. The first and second windows 2028, 2030 of the spacer arepositioned within the first and second groove 2029, 2031 on the firstand second lateral inner surfaces.

FIG. 19 shows the actuator member 2008, in the one embodiment which is alead screw that is retained within the spacer body 2002 by pressing thescrew past interfering lips in both the screw and spacer body 2002. Inthis embodiment the lead screw is provided with an acme thread, howevermost any thread profile may be used so long as the anchors 2004, 2006have a corresponding profile. The actuation member 2008 has drivingfeatures at both ends, such as a tri-lobe and is retained within theinner walls of the posterior portion of the implant. When the actuationmember 2008 is rotated, the actuation member does not translate in thelongitudinal direction. However, in other embodiments, the actuationmember 2008 may be configured to translate in the longitudinaldirection.

FIGS. 22 and 23 illustrates the instrument 2038 coupled to the implantin one embodiment of the invention. FIG. 22 specifically illustrates theimplant and the anchors in an undeployed state and FIG. 23 illustratesthe anchors 2004, 2006 in a deployed state. The instrument 2038 has aproximal end and a distal end, the distal end is configured to couple tothe implant through gripping elements. The gripping elements areconfigured to be attached to the slots provided on the lateral surfacesof the spacer body 2002. The instrument 2038 also includes a driverelement that is positioned between the gripping elements and extendsfrom the proximal end to the distal end of the implant. The driverelement is actuated by an actuation knob positioned at the proximal endof the instrument 2038. When the actuation knob is rotated in a firstdirection, the driver element rotates the actuation member 2008 of theimplant 2000 thereby causing the anchors 2004, 2006 to move and engagewith the vertebral bodies. When the actuation knob is rotated in asecond direction, the driver element rotates the actuation member 2008of the implant in a second direction, thereby causing the anchors 2004,2006 to move to disengage with the adjacent vertebral bodies and bepositioned within the spacer body 2002 of the implant. The grippingelements of the instrument 2038 are operated by the gripping knob. Whenthe gripping knob is rotated in a first direction, the gripping elementsare grip the lateral slots of the implant. When the gripping knob isrotated in a second direction, the gripping elements release theconnection with the implant by loosening the grip on the lateral slotsof the implant.

Now turning back to FIGS. 11, 20, and 21, the use and operation of theimplant will be discussed in greater detail. The implant 2000 ispositioned within the intervertebral space using the holder/instrument2038, each one of the anchors 2004, 2006 is configured to be deployedwith the rotation of the actuation member 2008 (in this case, clockwise)using the tri-lobe driver. The rotation of the actuation member 2008draws the anchors 2004, 2006 proximally which also drives them up thegrooves 2029, 2031 of the spacer body. This can be reversed by turningthe actuation member 2008 the other way. Specifically, the anchors 2004,2006 are moved or translated into the corresponding vertebral bodieswhen the actuation member 2008 is rotated in a first direction. When theactuation member 2008 is rotated in a second direction, the anchors2004, 2006 are moved to be positioned back within the spacer body 2002.In one embodiment, as the actuation member 2008 is rotated, one anchor2004 is guided towards the upper vertebral body and the second anchor2006 is guided towards the lower vertebral body. The first and secondanchors 2004, 2006 are guided simultaneously when the actuation member2008 is actuated. However, in other embodiments, the first and secondanchors 2004, 2006 may be moved independently of each other with oneactuation member 2008. In another embodiment, there may be provided withat least two actuation members that engage with each one of the anchors,thereby enabling each one of the anchors to be independently moved withrespect to the other anchor.

As illustrated in FIG. 11, each of the anchors 2004, 2006 are configuredto mate and correspond with the threads of the actuation member. As theactuation member is rotated, the threads of the actuation member 2008engage the partial threads of the anchors 2004, 2006, applying force onthe anchors 2004, 2006. The force applied by the actuation member 2008causes the anchors 2004, 2006 to move within the respective grooves2029, 2031 of the inner walls of the spacer body 2002. The grooves 2029,2031 guide each of the anchors 2004, 2006 as force is applied on theanchors, towards the upper and lower vertebral bodies.

The anchors 2004, 2006 are limited in movement by the protrusions 2032positioned within the windows 2030 of the lateral walls. In someembodiments, the windows 2030 can be configured with a radius and/ordifferent angles thereby provided varying movement of the anchors in tothe vertebral bodies. Additionally, the actuation member 2008 may bedriven from the other end using the smaller driving feature through thehole in the anterior surface of the spacer body 2002. In othercontemplated embodiments, the actuation member 2008 rather than beingrotated can be translated in a longitudinal axis from a posteriorportion of the implant to the anterior portion of the implant causingthe anchors 2004, 2006 to be deployed into the adjacent vertebralbodies. In another embodiment, the actuation member 2008 can beratcheting instrument which ratchets the anchors into the adjacentvertebral bodies.

In some embodiments, an alternative spacer and anchor system isprovided, as shown in FIGS. 24-33. The alternative spacer and anchorsystem provides a number of advantages. In particular, it comespre-assembled, such that it is easy and quick to insert. Furthermore,the alternative spacer and anchor system is easy to revise and remove ifnecessary via a threaded tube. Additional details of these advantagesare discussed below.

FIG. 24 depicts a top perspective view of an alternative spacer andanchor system in an undeployed state accordance with some embodiments.The spacer and anchor system comprises a spacer 2100 and a carrier 2150received in a slot 2130 formed in the spacer 2100. An upper anchor 2118is attached to an upper post 2162 of the carrier 2150, while a loweranchor 2120 is attached to a lower post 2164 (shown in FIG. 31) of thecarrier 2150. The carrier 2150 is advantageously capable of translatingalong the slot 2130 of the spacer 2100 via impaction. As the carrier2150 translates, this causes the upper anchor 2118 to be guided alonginner recesses or tracks 2124, 2126 (shown in FIG. 28) of the spacer2100 and the lower anchor 2120 to be guided along inner recesses ortracks 2134, 2136 of the spacer 2100, thereby causing deployment of theupper and lower anchors 2118, 2120.

As shown in FIG. 24, the spacer 2100 comprises a superior surface 2102,an inferior surface 2104, a first side surface 2106, second side surface2108, a leading or distal portion 2110 and a trailing or proximalportion 2112. The superior surface 2102 and inferior surface 2104 eachcomprise protrusions in the forms of ridges, pyramids, or teeth 2116that are designed engage adjacent vertebra. A through hole 2114 isformed through the superior surface 2102 and the inferior surface 2104and is designed to receive bone growth material, such as graft material.

As shown in FIG. 24, the first side surface 2106 and the second sidesurface 2108 each include a recess 2144 formed therein. Within each ofthe recesses 2144, one or more gripping holes 2146 are provided. Each ofthe gripping holes 2146 is configured to receive a portion of aninsertion instrument (e.g., a fork, tine or other protrusion). Theinsertion instrument can be used to deliver the spacer 2100 to a desiredposition within a disc space.

As shown in FIG. 24, the leading or distal portion 2110 of the spacer2100 comprises a tapered nose. The tapered nose can advantageously helpto distract a disc space as the spacer 2100 is inserted therein, therebyeasing insertion of the spacer 2100. The distal portion 2110 may alsoinclude an opening 2119. In addition, the trailing or proximal portion2112 can comprise a slot 2130, shown best in FIG. 29. A carrier 2150,having an upper anchor 2118 and a lower anchor 2120 attached thereto, isconfigured to be received and translate along the slot 2130. The spacer2100 includes a pair of upper recesses 2124, 2126 (shown in FIG. 25)that serve as guides or tracks for the upper anchor 2118. Likewise, thespacer 2100 includes a pair of lower recesses 2134, 2136 (shown in FIG.24) that serve as guides or tracks for the lower anchor 2120. As thecarrier 2150 translates along the slot 2130, the upper anchor 2118 isguided along the upper recesses 2124, 2126 and is deployed upwardly andoutwardly from the body of the spacer 2100. Likewise, the lower anchor2120 is guided along the lower recesses 2134, 2136 and is deployeddownwardly and outwardly from the body of the spacer 2100.

The carrier 2150 is configured to be received in the slot 2130 formed inthe proximal portion 2112 of the spacer 2100. The carrier 2150 includesa leading or front end 2152 and a trailing or rear end 2154. The carrier2150 is configured to enter the slot 2130 via its front end 2152. As thecarrier 2150 enters the slot 2130, inner sidewalls 2136, 2138 of thespacer 2100 (shown in FIG. 29) splay open to receive the carrier 2150therein. Impaction of the carrier's rear end 2154 causes the carrier2150 to translate within the slot 2130, thereby causing deployment ofthe upper and lower anchors 2118, 2120. In some embodiments, the carrier2150 comprises an upper post 2162 and a lower post 2164, as shown inFIGS. 30 and 31. The upper post 2162 is configured to receive an upperanchor 2118, while the lower post 2164 is configured to receive a loweranchor 2120. In addition, in some embodiments, the carrier 2150comprises a threaded portion 2158. As will be discussed in furtherdetail below, the threaded portion 2158 advantageously allows for easyrevision and removal of the spacer and anchor system if desired via athreaded tubular instrument. The threaded tubular instrumentadvantageously re-splays the inner sidewalls 2136, 2138 of the spacer2100 (shown in FIG. 29) if desired, thereby accommodating retraction ofthe upper and lower anchors 2118, 2120 if desired.

FIG. 25 depicts a top perspective view of the spacer and anchor systemof FIG. 24 in a deployed state. From this view, one can see the trailingor proximal portion 2112 of the spacer 2100, which includes the upperrecesses 2124, 2126 that serve as a guide or track for the upper anchor2118 and lower recesses 2134, 2136 that serve as a guide or track forthe lower anchor 2120. In this figure, the carrier 2150 has been pushedor impacted further into the slot 2130 of the spacer 2100, such that theupper anchor 2118 is deployed above the superior surface 2102 of thespacer 2100 and the lower anchor 2120 is deployed below the inferiorsurface 2104 of the spacer 2100. Advantageously, the deployed upperanchor 2118 is curved and configured to engage an upper vertebra, whilethe deployed lower anchor 2120 is curved and configured to engage alower vertebra.

FIG. 26 depicts a side view of the spacer and anchor system of FIG. 24in an undeployed state. From this view, one can see how far the carrier2150 extends outwardly from the proximal portion 2112 of the spacer 2100prior to deployment of the upper and lower anchors 2118, 2120. As thecarrier 2150 is impacted, this causes deployment of the upper and loweranchors 2118, 2120, and reduces the overall length of the spacer andanchor system.

FIG. 27 depicts a side view of the spacer and anchor system of FIG. 24in a deployed state. From this view, one can see how less of the carrier2150 extends outwardly from the proximal portion 2112 of the spacer 2100following impaction of the carrier 2150. In addition, one can see howthe upper anchor 2118 extends well above the superior surface 2102 ofthe spacer, while the lower anchor 2120 extends well below the inferiorsurface 2104 of the spacer upon their deployment. In some embodiments,the overall system including the spacer 2100, carrier 2150 and attachedanchors 2118, 2120 will all remain in a disc space of the patient.

FIG. 28 depicts a front perspective view of the spacer of FIG. 24. Thespacer 2100 comprises a superior surface 2102, an inferior surface 2104,a first side surface 2106 and a second side surface 2108. In addition,as shown in the figure, the spacer 2100 comprises a slot 2130 forreceiving a carrier 2150 (shown in FIG. 30) therein. The slot 2130 isbordered by a pair of inner sidewalls 2138, 2140 (shown in FIG. 29) thatare capable of splaying to receive and secure the carrier 2150 therein.Each of the sidewalls 2138, 2140 includes inner recesses that formguides or tracks for the upper and lower anchors 2118, 2120. As shown inFIG. 28, inner sidewall 2138 includes an upper recess 2124 and a lowerrecess 2134, while inner sidewall 2140 includes an upper recess 2126 anda lower recess 2136. The pair of upper recesses 2124, 2126 form a guidefor upper anchor 2118, while the pair of lower recesses 2134, 2136 forma guide for lower anchor 2120.

FIG. 29 depicts a top view of the spacer of FIG. 28. The features of theslot 2130 and its adjacent inner sidewalls 2138, 2140 of the spacer 2100are readily apparent. In some embodiments, inner sidewall 2138 comprisesan outer tapered surface 2134, while inner sidewall 2140 comprises anouter tapered surface 2136. As the carrier 2150 enters the slot 2130,tapered surfaces 2174, 2176 on the carrier (shown in FIG. 30) willengage with the outer tapered surfaces 2134, 2136, thereby causing theinner sidewalls 2138, 2140 to splay as the carrier 2150 is translated.As shown in FIG. 29, beyond each of the outer tapered surfaces 2134,2136 is a protruding locking surface 2135, 2137. As the carrier 2150(shown in FIG. 30) translates in the slot 2130 beginning with the frontend 2152, the inner sidewalls 2138, 2140 of the spacer 2100 will splay.Advantageously, as the carrier 2150 translates further, initial lockingsurfaces 2178, 2179 of the carrier 2150 will move past the protrudinglocking surfaces 2135, 2137 of the spacer 2100, thereby preventingbackout of the carrier 2150 once in the slot 2130 of the spacer 2100. Asthe carrier 2150 translates even further (e.g., to deploy the anchors2118, 2120), corner locking surfaces 2188, 2189 of the carrier 2150 willmove past the protruding locking surfaces 2135, 2137, thereby preventingbackout of the carrier 2150 and undesired retraction of the anchors2118, 2120. Accordingly, as shown in FIG. 29, the protruding lockingsurfaces 2135, 2137 of the spacer 2100 advantageously prevent undesiredbackout of the carrier 2150 by engaging with surfaces of the carrier2150.

FIG. 30 depicts a top view of a carrier of the spacer and anchor systemof FIG. 24. The carrier 2150 comprises a leading or front end 2152 and atrailing or rear end 2154. Adjacent the front end 2152, which is thefirst part of the carrier 2150 to enter the slot 2130 of the spacer2100, is a cylindrical front portion 2172. Beyond the cylindrical frontportion are the tapered surfaces 2174, 2176, which are designed toengage the outer tapered surfaces 2134, 2136 of the spacer 2100 toinitiate the splaying of the inner sidewalls 2138, 2140 of the spacer2100. The tapered surfaces 2174, 2176 are positioned adjacent initiallocking surfaces 2178, 2179 of the carrier 2150, which are designed toretain the carrier 2150 within the spacer 2100 (as discussed above) oncethe carrier 2150 has translated far enough along the slot 2130 of thespacer 2100. As shown in FIG. 30, the carrier 2150 further comprises atapered mid-section 2156 formed of tapered sidewalls. The taperedmid-section 2156 advantageously aids in the continuous splaying of theinner sidewalls 2138, 2140 of the spacer 2100 as the carrier 2150 istranslated therethrough. Note that as the carrier 2150 is translatedfurther into the spacer 2100, upper and lower anchors 2118 and 2120 thatare attached to upper and lower posts 2162, 2164 (shown in FIG. 31)begin to be deployed beyond the body of the spacer 2100. Followingdeployment of the anchors 2118, 2120, corner locking surfaces 2188, 2189of the carrier 2150 can engage the protruding locking surfaces 2135,2137 of the spacer 2100, thereby reducing the risk of backout of thecarrier and the deployed anchors. To translate the carrier 2150 withinthe spacer 2100, the rear end 2154 of the carrier 2150 can be impactedvia a tamp or other instrument.

As shown in FIG. 30, adjacent the rear end 2154 of the carrier 2150 is athreaded portion 2158. The purpose of the threaded portion 2158 is toprovide a surface upon which a removal or revision instrument 2180(shown in FIG. 33) can engage. The revision instrument 2180 includesinner threads 2184 that can mate with the threaded portion 2158 of thecarrier 2150. As the revision instrument 2180 is mateably threaded ontothe threaded portion 2158 of the carrier 2150, a tapered surface 2186 ofthe revision instrument 2180 can engage with the tapered surfaces 2134,2136 of the spacer 2100, thereby causing the inner sidewalls 2138, 2140to re-splay. With the sidewalls 2138, 2140 splayed open, the carrier2150 and its attached anchors 2118, 2120 are free to be retracted andwithdrawn from deployment. Accordingly, the spacer and anchor systemadvantageously provides a revision system capable of retracting anchorsvia the threaded portion 2158 of the carrier 2150 and the revisioninstrument 2180. Should a surgeon want to retract the deployed anchorsfor any reason, the present system provides a means to do so with ease,using a single revision instrument 2180.

FIG. 31 depicts a side view of a carrier of the spacer and anchor systemof FIG. 24. From this view, one can see the upper post 2162 and thelower post 2164 of the carrier 2150, which retain the upper and loweranchors 2118, 2120.

FIG. 32 depicts a side perspective view of an anchor of the spacer andanchor system of FIG. 24. The anchor is an upper anchor 2118, though oneskilled in the art will appreciate that the lower anchor 2120 includessimilar features. The upper anchor 2118 comprises a curved body having apair of tracks 2127, 2129 on opposing lateral sides. As the carrier 2150is translated in the slot 2130 of the spacer 2100, the track 2127 isconfigured to extend into inner recess 2124, while track 2129 isconfigured to extend into inner recess 2126 (shown in FIG. 25). Theupper anchor 2118 comprises a carrier hole 2128 for receiving an upperpost 2162 of the carrier 2150.

FIG. 33 depicts a side perspective view of a revision instrument inaccordance with some embodiments. The revision instrument 2180 comprisesa handle 2182 attached to a tubular body having a hollow, cannulatedinterior. On an opposite end of the handle 2182 is a tapered surface2186. As noted above, the tapered surface 2186 advantageously engagesouter tapered surfaces 2134, 2136 of the spacer 2100 (shown in FIG. 29),thereby causing the inner sidewalls 2138, 2140 of the spacer 2100 tore-splay as part of a desired revision. In addition, the revisioninstrument 2180 comprises inner threads 2184 that are capable ofengaging the threaded portion 2158 of the carrier 2150, to furtherassist in revision if desired.

In some embodiments, an inserter instrument can be provided to deliverthe spacer and anchor system into a desired disc space. The inserterinstrument can include forks or tines that grip the gripping holes 2146formed on the side of the spacer. In some embodiments, the inserterinstrument is cannulated so that other instruments, such as a tamp, canbe received therein. The tamp can be used to impact the rear end 2154 ofthe carrier 2150, thereby causing the carrier 2150 to translate withinthe slot 2130 of the spacer 2100. As the carrier 2150 translates, upperand lower anchors 2118, 2120 attached to the carrier are guided alongthe recesses within the spacer 2100 and deployed outwardly from thespacer.

An alternative spacer and anchor system is illustrated and describedwith respect to FIGS. 34-44. The spacer and anchor system advantageouslyprovides a spacer that is independent from a carrier for deployinganchors. With this configuration, the spacer can advantageously be usedon its own, or with the carrier and anchors attached to it. In addition,the spacer and anchor system in FIGS. 34-44 provides a novel means tosecure the anchors once deployed via a rotator. Furthermore, the spacerand anchor system in FIGS. 34-44 is provided with a means for revisionand removal if desired. All of these advantages are discussed below.

FIG. 34 depicts a side cross-sectional view of an alternative spacer andanchor system in accordance with some embodiments. The spacer and anchorsystem comprises a spacer 2200, a carrier 2250 attached to an upperanchor 2218 and a lower anchor 2220, and a rotator 2260. The spacer 2200is configured to fit into a disc space. The carrier 2250, which isindependent from the spacer 2200, is attachable to an upper anchor 2218and a lower anchor 2220. The carrier 2250 is configured to translateinto a slot 2230 (shown in FIG. 35) of the spacer 2200. As the carrier2250 translates, the upper anchor 2218 and the lower anchor 2220 areguided through recesses (e.g., such as recesses 2226 and 2236 shown inFIG. 34) and deployed outwardly from the body of the spacer 2200.Following deployment of the anchors 2218, 2220, the rotator 2260 can berotated to prevent backout of the anchors 2218, 2220 from deployment, aswill be discussed in more detail below.

The spacer 2200 comprises a superior surface 2202, an inferior surface2204, a distal portion 2210 and a proximal portion 2212. In someembodiments, the superior surface 2202 and inferior surface 2204 includeridges, pyramids or teeth 2216 to engage adjacent vertebrae. As shown inFIG. 34, the distal portion 2210 of the spacer 2200 comprises achamfered nose. Advantageously, the chamfered nose aids in distractionof vertebrae during insertion, thereby easing insertion of the spacer2200 into a disc space. The proximal portion 2212 of the spacer 2200comprises a slot 2230 (shown in FIG. 35). The slot 2230 is capable ofreceiving a carrier 2250 with anchors 2218, 2220 therein. To guide theanchors 2218, 2220, the spacer 2200 includes one or more recesses. Forexample, as shown in FIG. 34, the spacer 2200 comprises an upwardlycurved inner recess 2226 for guiding the upper anchor 2218, as well as adownwardly curved inner recess 2236 for guiding the lower anchor 2220 asthe carrier 2250 is translated through the slot 2230. In someembodiments, the spacer 2200 includes a pair of upper recesses thatserve as a track to guide the upper anchor 2218 and a pair of lowerrecesses that serve as a track to guide the lower anchor 2220, similarto the system shown in FIG. 25.

The carrier 2250 comprises a translatable body having an upper retainer2252 for retaining the upper anchor 2218 and a lower retainer 2254 forretaining the lower anchor 2220. In some embodiments, the carrier 2250is independent and detached from the body of the spacer 2200. Thecarrier 2250 is capable of translating in a slot 2230 of the spacer2200. As the carrier 2250 translates therein, anchors 2218, 2220attached to the carrier 2250 are deployed outwardly from the body of thespacer 2200. In some embodiments, the carrier 2250 comprises a rearthreaded portion 2258. The rear threaded portion 2258 is capable ofbeing engaged via a threaded sleeve 2292 (shown in FIG. 43). In someembodiments, the threaded sleeve 2292 provides a means for impaction ofthe carrier 2250, thereby allowing for translation of the carrier 2250and deployment of the anchors 2218, 2220.

The upper anchor 2218 and lower anchor 2220 are each attachable to thecarrier 2250 via the upper retainer 2252 and lower retainer 2254. Insome embodiments, the anchors 2218, 2220 are each curved and capable ofdigging into bone members. The anchors 2218, 2220 are capable of beingtranslated via the carrier 2250 into deployment.

In addition to the features described above, the spacer and anchorsystem comprises a novel rotator 2260. The rotator 2260 is configured toattach to the carrier 2250 via its trailing end 2268 (shown in FIG. 38).As the carrier 2250 translates, the rotator 2260 is also configured totranslate and anchors 2218, 2220 are deployed. As the anchors 2218, 2220are deployed, the rotator 2260 can be rotated such that engagement walls2264, 2266 of the rotator 2260 abut the anchors 2218, 2220, therebyreducing the risk of inadvertent back out of the anchors 2218, 2220.Furthermore, as the rotator 2260 is rotated, wings of a lead wall 2262of the rotator 2260 (shown in FIGS. 38 and 42) can be received inlocking slots 2208 (shown in FIG. 41) of the spacer 2200, therebysecuring the carrier, rotator and spacer.

FIG. 35 depicts a cross-sectional, exploded view of the spacer andanchor system of FIG. 34. From this view, one can see each of thecomponents before they are assembled. The spacer 2200 comprises a distalportion 2210 and a proximal portion 2212. A slot 2230 extends throughthe proximal portion 2212 of the spacer 2200. A carrier 2250 isconfigured to translate along the slot 2230 to cause deployment ofanchors attached to the carrier 2250.

The carrier 2250 comprises an upper retainer 2252 and a lower retainer2254. The upper retainer 2252 is configured to receive an upper anchor2218, while the lower retainer 2254 is configured to receive a loweranchor 2220.

The rotator 2260 comprises a leading end 2269 and a trailing end 2268.The leading end 2269 is configured to extend first into the spacer 2200.The trailing end 2268 is configured to be received in an aperture oropening 2255 of the carrier 2250 (shown in FIG. 37), such that therotator 2260 is attached to the carrier 2250. Between the leading end2269 and the trailing end 2268 is a lead wall 2262. In its upright,non-rotated position shown in FIG. 35, the lead wall 2262 comprises anupper wing 2265 and a lower wing 2267 that rise above and below,respectively, the rest of the rotator 2260. Upon rotation of the rotator2260, the upper wing 2265 will be received in a first locking slot 2208of the spacer 2200 (shown in FIG. 41), while the lower wing 2267 will bereceived in a second locking slot of the spacer 2200, thereby securingthe carrier 2250 to the spacer 2200. In some embodiments, a pair ofengagement walls 2264, 2266 are positioned adjacent to the lead wall2262. The engagement walls 2264, 2266 are configured such that uponrotation of the rotator 2260, the engagement walls 2264, 2266 engage thedeployed anchors 2218, 2220, thereby reducing the risk of inadvertentback-out of the deployed anchors 2218, 2220.

FIG. 36 depicts a top perspective view of a spacer in accordance withsome embodiments. From this view, one can see how the spacer 2200includes a graft hole 2214 that extends through a superior and inferiorsurface of the spacer 2200. Furthermore, one can see how the spacer 2200includes a slot 2230 for receiving the carrier 2250 (shown in FIG. 37)therein. Bordering the slot 2230 are adjacent sidewalls, each includingrecesses for guiding the upper and lower anchors 2218, 2220 therein. Insome embodiments, the spacer 2200 includes a pair of upper recesses2224, 2226 that serve as a curved track or guide for the upper anchor2218 and a pair of lower recesses 2234, 2236 that serve as a curvedtrack or guide for the lower anchor 2220.

FIG. 37 depicts a side perspective view of a carrier 2250 in accordancewith some embodiments. From this view, one can see how the carrier 2250includes an upper retainer 2252 for retaining an upper anchor 2218 and alower retainer 2254 for retaining a lower anchor 2220. In addition, thecarrier 2250 includes an opening 2255 that extends along itslongitudinal axis. The opening 2255 is configured to receive thetrailing end 2268 of the rotator 2260 (shown in FIG. 38), therebysecuring the rotator 2260 to the carrier 2250.

FIG. 38 depicts a side perspective view of a rotator in accordance withsome embodiments. From this view, one can see how the rotator 2260comprises a leading end 2269 and a trailing end 2268. Adjacent theleading end 2269 is a lead wall 2269 comprising an upper wing 2265 and alower wing 2267. The wings 2265, 2267 of the lead wall 2269 are capableof rotating into locking slots 2208 (shown in FIG. 41) of the spacer2200, thereby securing the rotator 2260 and carrier 2250 to the spacer2200. Adjacent the lead wall 2269 are engagement walls 2264, 2266. Uponrotation of the rotator, the engagement walls 2264, 2266 are configuredto abut the deployed anchors 2218, 2220 (as shown in FIG. 43), therebyadvantageously reducing the risk of inadvertent back out of the anchors2218, 2220. The trailing end 2268 of the rotator 2260 is capable ofbeing inserted into the carrier 2250, thereby securing the rotator 2260to the carrier 2250.

FIG. 39 depicts a top perspective view of an anchor in accordance withsome embodiments. The anchor shown in FIG. 39 is an upper anchor 2218,though one skilled in the art will appreciate that the lower anchor 2220includes similar features. In particular, the upper anchor 2218 andlower anchor 2220 comprise curved bodies that allow them to be guidedthrough curved recesses in the spacer 2200. As shown in FIG. 39, theupper anchor 2218 includes a carrier hole 2228 that allows forattachment to the upper retainer 2252 of the carrier 2250. Likewise, thelower anchor 2220 includes a similar carrier hole that allows forattachment to the lower retainer 2254 of the carrier 2250.

FIG. 40 depicts the spacer and anchor system of FIG. 34 including aninserter in accordance with some embodiments. The purpose of theinserter 2290 is to attach and deliver the spacer and anchor system to adesired disc space. In some embodiments, the inserter 2290 is forked ortined. In addition, in some embodiments, the inserter 2290 is cannulatedto receive one or more instruments therethrough, including the threadedsleeve 2292 shown in FIG. 41.

FIG. 41 depicts the spacer and anchor system of FIG. 34 including aninserter and threaded sleeve in accordance with some embodiments. Thepurpose of the threaded sleeve 2292 is to engage the rear threadedportion 2258 of the carrier 2250, thereby providing an impaction surfacefor impacting and translating the carrier 2250. The threaded sleeve 2292is optional. In other embodiments, the carrier 2250 can be impacted andtranslated directly via a tamp.

FIG. 42 depicts the spacer and anchor system of FIG. 34 including aninserter, threaded sleeve and key instrument prior to rotation of therotator, in accordance with some embodiments. As shown in the figure,the carrier 2250 has been translated such that anchors 2218, 2220attached to the carrier 2250 have been deployed. Once the anchors havebeen deployed, a key instrument 2294 can be delivered though theinserter 2290 and/or threaded sleeve 2292, and can be used to rotate therotator 2260. By rotating the rotator 2260, this advantageously causesthe upper wing 2265 and lower wing 2267 of the rotator 2260 to bereceived in locking slots 2208 (shown in FIG. 41), thereby securing therotator 2260 to the spacer 2200. In addition, by rotating the rotator2260, this advantageously causes the engagement walls 2264, 2266 of therotator 2260 to engage the anchors 2218, 2220, thereby reducing the riskof back out of the anchors 2218, 2220.

FIG. 43 depicts the spacer and anchor system of FIG. 34 including aninserter, threaded sleeve and key instrument following rotation of therotator, in accordance with some embodiments. From this view, one cansee how the engagement walls 2264, 2266 of the rotator 2260 engage theanchors 2218, 2220, thereby reducing the risk of back out of the anchors2218, 2220.

FIG. 44 depicts a top perspective view of the spacer and anchor systemof FIG. 34. From this view, one can see how the inserter 2290 engagesthe spacer and anchor system. In addition, one can see how the threadedsleeve 2292 is received in the inserter 2290. As noted above, thethreaded sleeve 2292 can engage the threaded portion 2258 of the carrier2250 (shown in FIG. 34), thereby providing an impaction surface toimpact and translate the carrier 2250. In some embodiments, the threadedsleeve 2292 can also be used to revise and remove the carrier 2250 andanchors 2218, 2220. By providing a gripping surface, the threaded sleeve2292 can be gripped, rotated and/or pulled, thereby helping to retractthe carrier 2250 and the anchors 2218, 2220 from deployment.

Turning now to FIGS. 45-49, an alternative spacer and anchor system isprovided. Spacer 2300 is similar to spacer 2100 described with respectto FIGS. 24-29 where like elements are identified the same, with theaddition of flexing tabs 2302. The flexing tabs 2302 located on thefirst and second side surfaces 2106, 2108 near the proximal portion 2112of the spacer 2300 are configured to engage the carrier 2150 and lockthe anchors 2118, 2120 in position (e.g., expanded/deployed position).

The flexing tabs 2302 extend from an integral, proximal end 2304 to afree, distal end 2306. Each of the flexing tabs 2302 is defined by aslot or cut-out 2308. The cut-out 2308 may be cut through the implantwalls from medial to lateral in order to define the flexing tabs 2303.The slot or cut-out 2308 may be in fluid communication with the innerslot 2130 and the respective recesses 2144. The cut-out 2308 may beconfigured as a substantially u-shaped slot. As best seen in FIG. 48,the cut-out 2308 extends along an upper portion 2310, a side portion2312 substantially perpendicular to the upper portion 2310, and a lowerportion 2314 substantially parallel to the upper portion 2310. Thecut-out 2308 provides for the moveable free end 2306, adjacent slot sideportion 2312, and for proximal end 2304 being integrally formed with therespective side walls 2106, 2108 of the spacer 2300. The cut-out 2308may include openings 2316 (e.g., curved or semi-cylindrical openings),proximate the proximal end 2304, which are enlarged relative to theremainder of the cut-out 2308.

As best seen in FIG. 49, each of the flexing tabs 2302 may be in theform of a tongue 2318 positioned along a plane 2320, 2322 extendingalong longitudinal axes of the spacer 2300. Planes 2320 and 2322 may besubstantially parallel to one another in a relaxed position (e.g., whenthe carrier is fully inserted and the anchors 2118, 2120 are locked inposition). The tongues 2318 are configured to flex outwardly from therespective planes 2320, 2322 such that the moveable free ends 2306 moveaway from one another when the carrier 2150 is moved from the initial,locked position (e.g., surfaces 2178, 2179) to the final, lockedposition (e.g., surfaces 2188, 2189). In other words, the tongues 2318are substantially parallel to one another in the initial and finallocked positioned and extend away from another (e.g., generally obliqueto one another) when the carrier 2150 is translating from the initial tothe final locked position. The tongues 2318 each have a hook orprotruding locking surface 2135, 2137 that extend towards one another.The tongues 2318 can flex out of and back into and position as thecarrier 2150 is moved. The tongues 2318 flex outwardly to accept thecarrier 2150, then snap closed into the locking slots 2188, 2189 on thecarrier 2150 in order to fix the carrier 2150 to the intervertebralspacer 2300.

In a first, retracted position (shown in FIG. 45), the anchors 2118,2120 are retracted and the carrier 2150 is inserted such that the hooks2135, 2137 are positioned within the initial locking surfaces 2178, 2179of the carrier. In a second, deployed position (shown in FIG. 46), theanchors 2118, 2120 are deployed and the carrier is fully inserted suchthat the hooks 2135, 2137 are positioned within the final lockingsurfaces 2188, 2189. The posts 2162, 2164 protruding from the superiorand inferior surfaces of the carrier 2150 engage with the anchors 2118,2120 and control their anterior-posterior position.

If desired, the anchors 2118, 2120 may be retracted after they have beendeployed. The threaded portion 2158 of the carrier 2150 allows theinserter 2180 to connect to the carrier 2150 allowing the user toretract the anchors 2118, 2120. To engage the carrier 2150, a threadedtube 2184 may be installed onto the carrier 2150. The tube 2184 may havea chamfered tip to engage the ramps 2324 on the flexing tabs 2302 of thespacer 2300. When threaded fully onto the carrier 2150, the tube 2180has spread the flexing tabs 2302 of the spacer 2300 enough to disengagethe lock 2188, 2189 and allow the carrier 2150 and anchors 2118, 2120 toreturn to the initial position (protrusions 2135, 2137 positioned withinsurfaces 2178, 2179) by pulling on the threaded tube 2180.

As shown in FIGS. 45-49, the spacer 2300 may also include one or morelateral windows 2330 positioned near the distal portion 2110 of thespacer 2300. The lateral windows 2330 may extend through the first andsecond side surfaces 2106, 2108 and into fluid communication with thethrough hole 2114 formed through the superior surface 2102 and theinferior surface 2104. The through hole 2114 and lateral windows 2330may be configured to receive bone growth material, such as graftmaterial.

The integrated anchor and spacer systems allow for fixation of thespacer to adjacent vertebrae. After the implant is placed betweenvertebral bodies, the fixation anchors can be deployed, which can helpto stabilize the position of the spacer and/or reduce the chance ofmovement or implant migration.

It is to be understood that the disclosure describes a few embodimentsand that many variations of the invention can easily be devised by thoseskilled in the art after reading this disclosure and that the scope ofthe present invention is to be determined by the following claims.

What is claimed is:
 1. An implantable system comprising: a spacer havinga superior surface, an inferior surface, a first side, a second side, adistal portion and a proximal portion, the first and second sidesdefining a slot therebetween in the proximal portion, the spacer furtherhaving a through hole that extends through the superior surface to theinferior surface, the first and second sides respectively having firstand second superior recessed tracks laterally facing each other, andrespectively having third and fourth inferior recessed tracks laterallyfacing each other; a first anchor having corresponding first and secondtracks adapted to ride on the first and second superior recessed tracksas a guide; a second anchor having corresponding first and second tracksadapted to ride on the third and fourth inferior recessed tracks as aguide; and a carrier carrying the first and second anchors, andpositioned within the slot and between the first and second anchors. 2.The system of claim 1, wherein the carrier has a post and the firstanchor has a corresponding carrier hole to receive the post.
 3. Thesystem of claim 1, wherein the carrier includes: a front portion adaptedto be received in the slot; and a threaded back portion adapted to bethreaded to a removal tool.
 4. The system of claim 3, further includingthe removal tool adapted to be threaded to the threaded back portion ofthe carrier to splay the first and second sides.
 5. The system of claim1, wherein the first and second sides respectively have first and secondtongues, each having an integral end and a free end and the free end hasa protruding locking surface.
 6. The system of claim 1, wherein thecarrier includes a pair of initial locking surfaces and a pair of finallocking surfaces.
 7. The system of claim 6, wherein in a retractedposition, the protruding locking surface of the first and second tonguesengage the pair of initial locking surfaces, and when moved to thedeployed position, the protruding locking surfaces of the first andsecond tongues engage the pair of final locking surfaces.
 8. The systemof claim 1, wherein: the proximal portion of the spacer includes firstand second tongues with each having an integral end and a free end; andthe free ends of the first and second tongues are moveable to engage thecarrier and lock the first and second anchors in a deployed position. 9.An implantable system comprising: a spacer having a superior surface, aninferior surface, a first side, a second side, a distal portion and aproximal portion, the first and second sides defining a slottherebetween in the proximal portion, the first and second sidesrespectively having first and second tongues each defined by a cut-out,each tongue having an integral end and a free end, wherein the spacerincludes a through hole that extends through the superior surface to theinferior surface, the first and second sides respectively having firstand second superior recessed tracks laterally facing each other, andrespectively having third and fourth inferior recessed tracks laterallyfacing each other; a first anchor having corresponding first and secondtracks adapted to ride on the first and second superior recessed tracksas a guide; a second anchor having corresponding first and second tracksadapted to ride on the third and fourth inferior recessed tracks as aguide; and a carrier positioned within the slot and between the firstand second anchors, wherein the free ends of the first and secondtongues are moveable to engage the carrier and lock the first and secondanchors in a deployed position.
 10. The system of claim 9, wherein thecut-out is in fluid communication with the slot.
 11. The system of claim9, wherein the cut-out is a substantially u-shaped slot.
 12. The systemof claim 9, wherein the first and second tongues each comprise aprotruding locking surface at the free end.
 13. The system of claim 12,wherein the carrier includes a pair of initial locking surfaces and apair of final locking surfaces.
 14. The system of claim 13, wherein in aretracted position, the protruding locking surface of the first andsecond tongues engage the pair of initial locking surfaces, and whenmoved to a deployed position, the protruding locking surfaces of thefirst and second tongues engage the pair of final locking surfaces. 15.The system of claim 9, wherein the carrier includes an upper post and alower post each for receiving a respective anchor.
 16. The system ofclaim 15, wherein the first anchor includes a carrier hole forattachment to the upper post of the carrier and the second anchorincludes a carrier hole for attachment to the lower post of the carrier.17. The system of claim 9, wherein the first and second superior tracksare curved.